ETORICOXIB TEVA 120 mg FILM-COATED TABLETS

2. What you need to know before taking Etoricoxib Teva

Do not take Etoricoxib Teva:

• if you are allergic to etoricoxib or any of the other ingredients of this medication (listed in section 6).
• if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) and COX-2 inhibitors (see Possible side effects, section 4).
• if you currently have a stomach ulcer or stomach or intestinal bleeding
• if you have severe liver disease
• if you have severe kidney disease
• if you are pregnant, may be pregnant, or are breastfeeding (see "Pregnancy, breastfeeding, and fertility")
• if you are under 16 years of age
• if you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis
• if you have uncontrolled high blood pressure (consult your doctor or nurse if you are unsure if your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), angina pectoris (chest pain)
• if you have had a heart attack, surgical revascularization, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including a transient cerebral attack or transient ischemic attack).

Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have already had heart problems or a stroke.

If you think you may be in any of these situations, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Teva if:

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example, as a result of prolonged illness with vomiting or diarrhea.
• You have swelling due to fluid retention.
• You have a history of heart failure or any other form of heart disease.
• You have a history of high blood pressure. Etoricoxib Teva may increase blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure from time to time.
• You have a history of liver or kidney disease.
• You are being treated for an infection. Etoricoxib Teva may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker, as these may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years old.

If you are unsure whether any of the above situations apply to you, talk to your doctor before taking Etoricoxib Teva to check if this medication is suitable for you.

Etoricoxib Teva works just as well in adult and young patients. If you are over 65 years old, your doctor will want to keep a close eye on you. No dose adjustment is necessary in patients over 65 years old.

Children and adolescents

Do not give this medication to children and adolescents under 16 years of age.

Taking Etoricoxib Teva with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those purchased without a prescription.

In particular, if you are taking any of the following medications, your doctor may want to monitor you to check that your medications are working properly once you start taking Etoricoxib Teva:

• medications that make your blood less thick (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medication used to suppress the immune system and often used in rheumatoid arthritis)
• cyclosporin or tacrolimus (medications used to suppress the immune system)
• lithium (a medication used to treat some types of depression)
• medications used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics (water pills)
• digoxin (a medication for heart failure and irregular heartbeat)
• minoxidil (a medication used to treat high blood pressure)
• tablets or oral solution of salbutamol (a medication for asthma)
• oral contraceptives (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• acetylsalicylic acid (aspirin), the risk of stomach ulcers is higher if you take Etoricoxib Teva with acetylsalicylic acid.

• acetylsalicylic acid for the prevention of heart attacks or stroke:
• Etoricoxib Teva can be taken with low doses of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or stroke, do not stop taking acetylsalicylic acid until you talk to your doctor
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):
• do not take high doses of acetylsalicylic acid or other anti-inflammatory medications while taking Etoricoxib Teva

Pregnancy, breastfeeding, and fertility

Pregnancy

Etoricoxib Teva should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have any doubts or need more information.

Breastfeeding

It is not known if etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib Teva. If you are using Etoricoxib Teva, do not breastfeed.

Fertility

Etoricoxib Teva is not recommended for use in women who are trying to become pregnant.

Driving and using machines

In some patients taking Etoricoxib Teva, dizziness and drowsiness have been reported.

Do not drive if you experience dizziness or drowsiness.

Do not use tools or machines if you experience dizziness or drowsiness.

3. How to take Etoricoxib Teva

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

There are different doses available for this medication, and depending on your disease, your doctor will prescribe the tablet with the dose that is suitable for you.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once a day, increasing to a maximum of 60 mg once a day if necessary.

Rheumatoid arthritis

The recommended dose is 60 mg once a day, increasing to a maximum of 90 mg once a day if necessary.

Ankylosing spondylitis

The recommended dose is 60 mg once a day, increasing to a maximum of 90 mg once a day if necessary.

Acute pain situations

Etoricoxib should only be used during the period of acute pain.

Gout

The recommended dose is 120 mg once a day, which should only be used during the period of acute pain, limited to a maximum of 8 days of treatment.

Postoperative dental pain

The recommended dose is 90 mg once a day, limited to a maximum of 3 days of treatment.

Patients with liver problems

• If you have mild liver disease, do not take more than 60 mg per day.
• If you have moderate liver disease, do not take more than 30 mg per day.

Do not take more than the recommended dose for your disease. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and do not take Etoricoxib Teva for longer than necessary. This is because the risk of heart attacks and strokes could increase after prolonged treatment, especially with high doses.

Use in children and adolescents

Children or adolescents under 16 years of age should not take Etoricoxib Teva.

Elderly patients

No dose adjustment is necessary in elderly patients. As with other medications, caution should be exercised in elderly patients.

Method of administration

Etoricoxib Teva is administered orally.

Take the tablets once a day. Etoricoxib Teva can be taken with or without food.

If you take more Etoricoxib Teva than you should

Never take more tablets than your doctor recommends. If you take too many Etoricoxib Teva tablets, seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Etoricoxib Teva

It is important that you take Etoricoxib Teva as your doctor has indicated. If you forget a dose, simply resume your usual regimen the next day.

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you develop any of these signs, stop taking Etoricoxib Teva and talk to your doctor immediately (see section 2 What you need to know before taking Etoricoxib Teva):

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe or persistent stomach pain or your stools become black
• an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing

The following side effects may occur during treatment with Etoricoxib Teva:

Very common(may affect more than 1 in 10 people)

• stomach pain

Common(may affect up to 1 in 10 people)

• alveolar osteitis (inflammation and pain after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heartbeat (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophagitis, mouth ulcers
• changes in blood tests related to your liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon(may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (an allergic reaction including hives that can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental sharpness; seeing, feeling, or hearing things that do not exist (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing)
• abnormal heartbeat (atrial fibrillation), rapid heartbeat, heart failure, feeling of tension, pressure, or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, transient ischemic attack (mini-stroke), severe increase in blood pressure. Inflammation of blood vessels
• cough, difficulty breathing, nosebleed
• stomach or intestinal swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in the blood, changes in blood or urine tests related to your kidneys, severe kidney problems
• chest pain

Rare(may affect up to 1 in 1,000 patients)

• angioedema (an allergic reaction with swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction that requires immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver disorder, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Etoricoxib Teva

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Etoricoxib Teva Composition

The active ingredient is etoricoxib.

Each film-coated tablet contains 30 mg of etoricoxib.

Each film-coated tablet contains 60 mg of etoricoxib.

Each film-coated tablet contains 90 mg of etoricoxib.

Each film-coated tablet contains 120 mg of etoricoxib.

• Other components are:

Core: hydrogenated calcium phosphate (anhydrous), crospovidone (type A), microcrystalline cellulose, povidone K25, magnesium stearate.

Tablet coating: hypromellose, hydroxypropylcellulose, talc, medium-chain triglycerides, titanium dioxide (E171), microcrystalline cellulose (30 mg), red iron oxide (30 mg) (E172), aluminum lake indigo carmine (30, 60, and 120 mg) (E132), aluminum lake brilliant blue (60 and 120 mg) (E133), yellow iron oxide (60 and 120 mg) (E172), black iron oxide (60 and 120 mg) (E172).

Product Appearance and Package Contents

30 mg film-coated tablet, blue, round, biconvex, marked with "30" on one side and smooth on the other.

60 mg film-coated tablet, dark green, round, biconvex, marked with "60" on one side and smooth on the other.

90 mg film-coated tablet, white, round, biconvex, marked with "90" on one side and smooth on the other.

120 mg film-coated tablet, light green, round, biconvex, marked with "120" on one side and smooth on the other.

Package sizes:

30 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 14, 28, 28x1, 30, 98 film-coated tablets.

60 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

90 mg

OPA/Alu/PVC - Aluminum blister packs containing 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

120 mg

OPA/Alu/PVC - Aluminum blister packs containing 5, 7, 7x1, 14, 16, 20, 28, 28x1, 30 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Gyógyszergyár Zrt.

Debrecen, Pallagi út 13,

H-4042

Hungary

or

Teva Nederland BV

Swensweg 5, Haarlem

2031 GA

Netherlands

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, Opava-Komarov

74770

Czech Republic

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80,

Krakow, 31-546

Poland

or

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica,

Zaragoza, 50016

Spain

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

Blaubeuren, 89143

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000

Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: ??????????? ???? 30 mg, 60 mg, 90 mg, 120 mg ????????? ????????

Croatia: Coxeta 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Estonia: Etoricoxib Teva

Germany: Etoricox-AbZ 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Ireland: Etoricoxib Teva 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Italy: ETORICOXIB TEVA

Latvia: Etoricoxib Teva 60mg, 90 mg, 120 mg film-coated tablets

Lithuania: Etoricoxib Teva 30 mg, 60mg, 90 mg, 120 mg film-coated tablets

Malta: Etoricoxib Teva 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Poland: Etoricoxib Teva

Portugal: Etoricoxib Teva

Romania: ETORICOXIB TEVA 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Slovenia: Coxeta 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Spain: Etoricoxib Teva 30 mg, 60 mg, 90 mg y 120 mg film-coated tablets EFG

Sweden: Etoricoxib Teva 30 / 60 / 90 / 120 mg film-coated tablets

Netherlands: Etoricoxib Teva 30 mg, 60 mg, 90 mg, 120 mg, film-coated tablets

United Kingdom: Etoricoxib 30mg, 60mg, 90mg & 120mg film-coated tablets

Date of the last revision of thisleaflet:September 2016

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)